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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G GAS CONTROL UNIT. CARDIOPULMONARY BYPASS

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SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G GAS CONTROL UNIT. CARDIOPULMONARY BYPASS Back to Search Results
Model Number 3500CP-G
Device Problem Infusion or Flow Problem (2964)
Patient Problem Hypoxia (1918)
Event Date 01/04/2021
Event Type  Death  
Manufacturer Narrative
This report is based solely on the customers reported issue. The device was requested to be returned for evaluation and has not been received. Dhr review for the sechrist mixer found no indication that there were any relevant discrepancies during manufacture of the device and no non-conformance that could have caused or contributed to the reported issue. At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. Manufacturers reference file #(b)(4).
 
Event Description
Customer reported a patient supported on vv ecmo. The patient's saturations were below target abg performed which had a lower pao2 than target. A post oxygenator membrane gas was done, this had a low pao2 and sao2 this suggested an oxygenator issue. While troubleshooting this it was noticed the blender dial was loose and came off. The oxygen supply was switched to a cylinder and oxygenation improved. The post-oxygenator gas would suggest less than 100% oxygen was being delivered. The blender was removed from use while being investigated. Customer also reported, it is a loan device from another centre. Two small grubber screws have come loose meaning the dial is not attached firmly to control spindle. The device was serviced and calibrated 7/14/2020. It was also inspected by our hospital medical physics prior to use. Ce mark 1639 the patient became hypoxic for a short period of time. No obvious harm but there was a deterioration in renal function but this was more likely to be due to septic episode but could have been caused by hypoxia.
 
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Brand NameSECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G
Type of DeviceGAS CONTROL UNIT. CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC
4225 e. la palma ave.
anaheim CA 92807
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC
4225 e. la palma ave.
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4225 e. la palma ave.
anaheim, CA 92807
7145798309
MDR Report Key11340465
MDR Text Key232278132
Report Number2020676-2021-00001
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K023745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3500CP-G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
Treatment
VV ECMO CHALICE PARAGON OXYGENATOR
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